Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016807211

FEI Number

3016807211

Entity Name

JIANGSU GUANGYI MEDICAL DRESSING CO.,LTD.

City/State/Country

Lianyungang Jiangsu, CN

Establishment Address

No.6 Jianzhong Road,Xinpu Economic and Development Zone,Haizhou District, Lianyungang Jiangsu 222344, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

JIANGSU GUANGYI MEDICAL DRESSING CO., LTD. (Owner Number: 10067641)

Owner / Operator Contact Address

No.6 Jianzhong Road,Xinpu Economic Development Zone, Haizhou District, Lianyungang, CN-JS 222344, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Non-woven Pads/Sponges, Non-woven Gauze Pads/Sponges Nonwoven Eye Pads/Patches, Adhesive Wound Dressing, Bordered Gauze, Absorbent Wound Care Dressing, Transparent Island Dressing, Transparent Film Dressing, Transparent film Eye Pads/Patches Sterile Island Dressing, Bordered Gauze Dressing, Adhesive Island Dressing, Absorbent Gauze Dressing, Wound Dressing, Advanced Wound Dressing, Foam Dressing, Silicon Foam Dressing, Island Dressing, Tattoo bandages, Tattoo Aftercare Bandages, Tattoo Protective Film, Tattoo Film, Waterproof Transparent Film Dressing Non-woven Tape, Ear Stickers/Covers/Patches, Waterproof Ear Stickers/Covers/Patches, Catheter Stabilization Device/Dressing, Band-aid, Adhesive Bandages, Adhesive Strips, Breathable Bandages, Bandages, Transparent Film Dressing, Transparent Dressing, Medical Tape, Surgical Tape, Stretch Tape, Stretch Non-woven Bandages, Baby Waterproof Ear Stickers/Covers/Patches, Ear Protectors, Catheter Fixing Dressing/Device, Adhesive bandages, Silicon Bandages, Waterproof Bandages Hydrocolloid dressing Gauze pads/Sponges

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2020-04-06
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2020-04-06
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2020-04-06
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2020-04-06
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2020-04-06
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2020-04-06

Official Correspondent

Beibei Miao

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

JIANGSU GUANGYI MEDICAL DRESSING CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

Registration Number	Establishment Name	Location
3011050528	FREEHOLD SURGICAL, INC.	New Hope, PA, US
3021006167	KIMS MED CO., LTD.	Gwangju, KR
3045009502	WISDOM MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD	Shanghai, CN
3032847175	BIOPHYX SURGICAL, INC.	Edgewater, MD, US
9681129	BEMA-GMBH & CO. KG	EMMINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016807211. Last updated year: 2026. Please use registration number 3016807211 when referencing this establishment in official correspondence.